Clinical Trials

Medical research advances at Community Hospital

The scientific breakthroughs that bring us new drugs, new medical devices, and new approaches to treatment are born of painstaking clinical trials that play out every day in laboratories and healthcare centers around the world, including Community Hospital.

"It’s something that many people are not aware of, but research really does take place throughout the hospital," says Kay Lee, coordinator of Community Hospital’s Institutional Review Board (IRB), which has approval and oversight responsibilities for all research studies conducted at the hospital.

The closely monitored studies are designed to determine the level of safety and to identify risks and benefits of drugs, devices, and treatments. At any given time, more than three dozen trials may be under way at the hospital. That number has grown markedly over the years, says Therese Beauclair, assistant director of Pharmacy and the current IRB chairperson.

"Every drug and device that is approved by the Food and Drug Administration starts with an experiment," says Beauclair. "We now have studies being conducted that may result in a process that removes uterine fibroids using radiofrequency waves rather than invasive surgery, or in a wrist band that helps control nausea and vomiting in cancer patients. It’s gratifying to know that we are participating in clinical research that may benefit our community in such a positive way."

Among other current or recent clinical trials at Community Hospital are:

• Investigation of a drug used in conjunction with chemotherapy or radiation therapy that is being tested for its effectiveness in treating cancer of the prostate, lung, colon, pancreas, or breast

• A comparative research procedure to determine whether women who have breast cancer do better when they undergo partial- versus whole-breast irradiation

• A coronary stent graft available on an emergency basis for repairing an unexpected hole or holes in a coronary artery

• A data-collection study that assesses the efficacy of the hospital’s current protocol on reducing heel sores

• A data-collection study that tracks treatment outcomes of subjects who are experiencing precancerous changes to the esophagus to determine whether a surgical procedure proved effective

Getting to the investigative stage can be as painstaking as the research itself. Before 1950, there was almost no regulation of human research, according to Dr. Anthony Chavis, vice president of medical affairs and patient safety officer for Community Hospital. That changed because of a string of atrocities in the United States and abroad, including experiments on unwitting subjects and mistreatment of people, such as the mentally ill, who couldn’t fend for themselves.

"These boards act in the sole interest of human research subjects to ensure their safety, dignity, and quality of care in biomedical and behavioral research."

"Historically, individuals who carried out human-subject research have, at times, abused the rights, the safety, and the dignity of research subjects. The result was the National Research Act of 1974, which created the institutional review board system," says Chavis, a Community Hospital IRB member. "These boards act in the sole interest of human research subjects to ensure their safety, dignity, and quality of care in biomedical and behavioral research."

All human research in the United States that receives federal funds must be approved by an IRB.

By design, the boards consist of clinical and nonclinical members. The nonclinical members represent the community at large, to look at potential research from a layperson’s perspective and to judge whether it is appropriate and related documentation is clear. The 13 voting members of Community Hospital’s IRB include a pastor, a librarian, a community college researcher, and a lawyer. Physicians, pharmacists, and nurses provide the clinical expertise.

The board meets monthly to consider new trials, review those in progress, and discuss any regulatory changes.

The trials are formally proposed to the IRB by a researcher, who may be a doctor, pharmacist, nurse, or dietitian, for example.

Lee and Beauclair review the documentation, sometimes ask for changes, then take the proposal to the full board for consideration. The researcher, now called the principal investigator, appears before the board to describe the proposal and answer questions. Afterward, the board discusses the protocol and may approve or deny the study, or ask for changes or more information.

"The IRB members spend hours scrutinizing consent documents and applying the scientific method to new protocols to ensure that the research is valid and that it is done with goodwill and respect for our human subjects," Beauclair says.

"The board reviews an average of one new proposal a month," Lee says. "Most are approved, but only after rigorous review and debate.

‘Dedicated to preserving human dignity,’ is our board’s mission statement," Lee adds. "This means we protect the rights and welfare of all human subjects participating in research studies at the hospital. The board also reviews these studies to ensure we are in compliance with all federal and state regulations."

The trials move through four phases. In the first phase, researchers test a new drug, treatment, or device on a small group of subjects — up to 80 people — for the first time. The goal is to evaluate safety, determine appropriate dosages, and identify potential side effects. The second phase involves up to 300 subjects and evaluates effectiveness and safety. In the third phase, up to 5,000 subjects are enrolled and comparisons are made with the current standard treatment. The fourth phase, which comes after the drug, device, or treatment has been approved by the Food and Drug Administration, collects information on the best uses over time.

Research subjects are voluntary participants who may be healthy or under medical care. They enter into the research process only after receiving complete information about the protocol, the potential risks, and the potential benefits of participation. They are able to withdraw at any time without penalty.

Lee says it’s important that subjects understand that their participation should not be considered a cure for their illness. Rather, she says, they are contributing to developing treatment strategies for future outcomes.

"Organizations that advertise research as immediate cures raise ethical questions," she says.

Lee says the trials are good for the hospital, the community, and researchers.

"For our local principal investigators, it’s another means of staying abreast of current exploratory strategies, drugs, or devices. Research can also open opportunities to re-evaluate current procedures, or to test for improvements. For the hospital, it’s another means of listening to the needs of the community by providing opportunities to consider alternative interventions locally while contributing to the development of improved treatment." ~